Background
Methods
Study site and recruitment procedures
Enrolment
Randomization and masking
Drugs and regimen
Follow-up
Sample size
Laboratory tests and outcome measurement
Polymerase chain reaction (PCR)
Statistical analysis
Ethical approval
Results
Patient recruitment and participant flow
Characteristic | Treatment arm | |||
---|---|---|---|---|
Number of patients | AP (n = 110) | DHP (n = 55) | AL (n = 55) | P value |
Gender: Male/Female(ratio) | 72/28(2.57) | 43/12(3.58) | 46/9(5.11) | NSa |
Mean age, years(range) | 25.2(7-55) | 21.9(8-64) | 27.4(7-58) | NS |
Age Groups: | ||||
7-10 | 11(10.0%) | 2(3.6%) | 5(9.1%) | NS |
11-15 | 16(14.54%) | 5(9.1%) | 5(9.1%) | NS |
> 15 | 83(75.46%) | 48(87.3%) | 45(81.8%) | NS |
mean duration of fever (in days) (range) | 4.2 (1.3-7.1) | 4.6 (1.3-7.9) | 5.3 (1.1-9.5) | NS |
Mean parasitaemia (1 ×/μl)(range) | 26637(3801-49473) | 25850(195-51505) | 31297(1215-61379) | NS |
Body temperature (°C), mean (range) | 38.5(37.7-39.3) | 38.8 (37.7-39.9) | 38.8(37.7-39.9) | NS |
Hepatomegly rate (%) | 5.5 | 14.5 | 7.3 | NS |
Splenomegly rate (%) | 26.4 | 21.8 | 12.7 | NS |
Treatment effectiveness
Therapeutic response | AP (n = 110) | DHP (n = 55) | AL (n = 55) |
---|---|---|---|
Excluded(%) | 0 | 0 | 0 |
Lost of follow-up (%) | 0 | 0 | 0 |
Early Treatment Failure(%) | 0 | 0 | 0 |
Late Clinical Failure(%, 95%CI) | 13(11.8, 5.79~17.85%) | 1(1.8, -1.71~5.34%) | 13(23.6,12.41~34.86%) |
ACPR (%, 95% CI) on D14 on D21 on D28 | 109 (99.1, 97.31~100.86%) 105(95.5, 91.56%~99.35%) 97(88.2, 82.15%~94.21%) | 55(100, 93.6%~100%) 55(100, 93.6%~100%) 54(98.2, 94.65~101.71%) | 54(98.2, 94.65~101.71%) 48(87.3, 78.46%~96.08%) 42(76.4, 65.14%~87.59%) |
ACPR by Intention-to-treat analysis on D28 (%) | 97/110 (88.2) | 54/55 (98.2) | 42/55 (76.4) |
ACPR adjusted by PCR on D28 (%) | 97/102*▲ (95.1) | 54/55 (98.2) | 42/51 (82.4) |
Parasite clearance time, mean ± SD hours | 66.7 ± 21.9*Δ | 65.6 ± 27.3Δ | 65.3 ± 22.5 |
Fever clearance time, mean ± SD hours | 31.6 ± 17.7*Δ | 34.6 ± 21.8 | 36.9 ± 15.4 |